ISO 8537:2016
Sterile single-use syringes, with or without needle, for insulin
ISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.
The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.
ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$281.74 NZD
|
|
| HardCopy |
$319.13 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Types of syringes
5 Requirements
5.1 General requirements
5.2 Material selection
5.3 Colour coding
5.4 Extraneous matter
5.4.1 General
5.4.2 Limits for acidity or alkalinity
5.4.3 Limits for extractable metals
5.5 Lubrication
5.5.1 Lubrication of syringes
5.5.2 Lubrication of needle tube
5.6 Dimensions
5.6.1 Barrel and plunger stopper
5.6.2 Finger grips
5.7 Plunger/plunger stopper
5.7.1 General
5.7.2 Fit of plunger stopper in barrel
5.8 Nozzle
5.8.1 Conical fitting
5.8.2 Position of nozzle on end of barrel
5.9 Needle tubing and needles
5.9.1 Needles for syringe types 3 and 4
5.9.2 Needle tubing for syringe types 5, 6, 7 and 8
5.9.3 Bond between hub and needle tube
5.10 Standard test environmental conditions
5.11 Performance of assembled syringe
5.11.1 Dead space
5.11.2 Freedom from leakage at needle
5.11.3 Freedom from leakage past plunger stopper
6 Packaging
6.1 Unit packaging and self-contained syringe units
6.1.1 General
6.1.2 Unit packaging providing sterile barrier syringes (types 1, 3, 5 and 7)
6.1.3 Self-contained syringes with sterile interiors (types 2, 4, 6 and 8)
6.2 Multiple-unit packaging (for syringe types 2, 4, 6 and 8)
6.3 User packaging
7 Information supplied by the manufacturer
7.1 General
7.2 Syringes
7.2.1 General
7.2.2 Additional marking for self-contained syringes (syringe types 2, 4, 6 and 8)
7.3 Unit packaging (for syringe types 1, 3, 5 and 7)
7.4 Multiple unit packs (syringe types 2, 4, 6 and 8)
7.5 User packaging
7.6 Storage container
7.7 Transport wrapping
Annex A (normative) Fluid for determination of acidity/alkalinity and extractable metals
Annex B (normative) Test method for air leakage past syringe piston during aspiration and for separation of rubber stopper and plunger
Annex C (normative) Test method for determination of forces required to operate piston
Annex D (normative) Test method for determination of dead space
Annex E (normative) Test method for liquid leakage at syringe piston and syringe nozzle/hub or needle/barrel unions during compression
Annex F (normative) Test method for air leakage past nozzle/hub or needle/barrel unions during aspiration
Annex G (normative) Preparation of extract for test for pyrogenicity and toxicity
Annex H (normative) Syringe sizes and graduated scales
Bibliography
Previous versions
Keep me up-to-date
Register to receive notifications when updates are made to this standard.
Related Information
Similar Standards
-
AS/NZS IEC 60601.2.16:2015
Medical electrical equipment - Part 2.16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment -
BS 1263-1:1989
Reusable hypodermic syringes for medical use., Specification for dimensions of all-glass and metal-and-glass syringes
-
BS 6196:1989
Specification for sterile epidural catheters and introducer needles for single use
-
BS EN 12439:1999
Sterile rectal catheters for single use
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Types of syringes
5 Requirements
5.1 General requirements
5.2 Material selection
5.3 Colour coding
5.4 Extraneous matter
5.4.1 General
5.4.2 Limits for acidity or alkalinity
5.4.3 Limits for extractable metals
5.5 Lubrication
5.5.1 Lubrication of syringes
5.5.2 Lubrication of needle tube
5.6 Dimensions
5.6.1 Barrel and plunger stopper
5.6.2 Finger grips
5.7 Plunger/plunger stopper
5.7.1 General
5.7.2 Fit of plunger stopper in barrel
5.8 Nozzle
5.8.1 Conical fitting
5.8.2 Position of nozzle on end of barrel
5.9 Needle tubing and needles
5.9.1 Needles for syringe types 3 and 4
5.9.2 Needle tubing for syringe types 5, 6, 7 and 8
5.9.3 Bond between hub and needle tube
5.10 Standard test environmental conditions
5.11 Performance of assembled syringe
5.11.1 Dead space
5.11.2 Freedom from leakage at needle
5.11.3 Freedom from leakage past plunger stopper
6 Packaging
6.1 Unit packaging and self-contained syringe units
6.1.1 General
6.1.2 Unit packaging providing sterile barrier syringes (types 1, 3, 5 and 7)
6.1.3 Self-contained syringes with sterile interiors (types 2, 4, 6 and 8)
6.2 Multiple-unit packaging (for syringe types 2, 4, 6 and 8)
6.3 User packaging
7 Information supplied by the manufacturer
7.1 General
7.2 Syringes
7.2.1 General
7.2.2 Additional marking for self-contained syringes (syringe types 2, 4, 6 and 8)
7.3 Unit packaging (for syringe types 1, 3, 5 and 7)
7.4 Multiple unit packs (syringe types 2, 4, 6 and 8)
7.5 User packaging
7.6 Storage container
7.7 Transport wrapping
Annex A (normative) Fluid for determination of acidity/alkalinity and extractable metals
Annex B (normative) Test method for air leakage past syringe piston during aspiration and for separation of rubber stopper and plunger
Annex C (normative) Test method for determination of forces required to operate piston
Annex D (normative) Test method for determination of dead space
Annex E (normative) Test method for liquid leakage at syringe piston and syringe nozzle/hub or needle/barrel unions during compression
Annex F (normative) Test method for air leakage past nozzle/hub or needle/barrel unions during aspiration
Annex G (normative) Preparation of extract for test for pyrogenicity and toxicity
Annex H (normative) Syringe sizes and graduated scales
Bibliography